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Psilocybin-assisted CBT for Depression

Phase < 1

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria

Able to swallow capsules

Must not have

Any of the following cardiovascular conditions

Current use of antidepressants or other serotonergic-affecting substances

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-month study period

Awards & highlights

Summary

This trial studies how combining psilocybin (a psychedelic) with therapy helps treat depression. Two doses of psilocybin are given during 12 therapy sessions, and participants are followed for 4 months.

Who is the study for?

This trial is for adults aged 21-60 with depression, who are experiencing a major depressive episode. They must be able to swallow capsules and have someone to drive them home after sessions. Women should use effective contraception. Exclusions include active suicidality, current antidepressant use, certain cardiovascular conditions, insulin-dependent diabetes, history of psychosis or bipolar in the family, prior adverse reaction to psychedelics, pregnancy or nursing.

What is being tested?

The study tests combining psilocybin (a psychedelic drug) with cognitive-behavioral therapy (CBT) for treating major depressive disorder. Participants will receive two oral doses of psilocybin during twelve CBT sessions over four months and then be followed up for three additional months.

What are the potential side effects?

Possible side effects from psilocybin may include nausea, headache, dizziness, increased heart rate and blood pressure changes shortly after taking it. Some might experience emotional distress or confusion during the psychoactive phase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression now or in the past.

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I can swallow pills.

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I am between 21 and 60 years old.

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I am currently experiencing significant depression symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition.

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I am currently taking antidepressants or medications that affect serotonin.

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I have epilepsy or a history of seizures.

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I have had a stroke or a transient ischemic attack.

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I use insulin to manage my diabetes.

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I do not have current suicidal thoughts or severe psychiatric issues needing immediate care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-month study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-month study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-month study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global Assessment of Functioning

Hamilton Depression Rating Scale

Treatment acceptability

+1 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Psilocybin + CBTExperimental Treatment1 Intervention

All participants will receive 12 sessions of cognitive-behavioral therapy (CBT) along with two psilocybin-drug sessions -- the first following the third CBT session (10mg of psilocybin, taken orally) and the second following the sixth CBT session (25mg of psilocybin, taken orally).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

0 / 10Eligibility criteria met